[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644723":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":53,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":20,"maxAge":20,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University Hospital, Essen","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MC4R Therapy","EXPERIMENTAL","Patients receiving approved MC4 receptor agonists according to licensed indications and routine clinical practice.",[13],"Drug: Setmelanotide",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Setmelanotide","Administration according to approved product labeling and treating physician discretion",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Metin Cetiner, PD Dr. med.","Universitätsmedizin Essen","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Tom Hühne, Dr. med.","CONTACT","+49 201 723 86211","tom.huehne@uk-essen.de",{"name":33,"role":29,"phone":20,"phoneExt":20,"email":34},"Lars Dinkelbach, Dr. med.","lars.dinkelbach@uk-essen.de",[36],{"facility":37,"status":38,"city":39,"state":20,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University Hospital Essen, Deparment of Pediatrics II","RECRUITING","Essen","45147","Germany","DE",{"type":44,"coordinates":45},"Point",[46,47],7.01228,51.45657,{"lat":47,"lon":46},[50],{"name":23,"role":29,"phone":51,"phoneExt":20,"email":52},"+49 201 723 84722","metin.cetiner@uk-essen.de",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Tom Hühne","Deputy Director, Medical Coordination in the Center of Excellence Bardet-Biedl Syndrome",[58],{"name":59,"class":60},"Rhythm Pharmaceuticals, Inc.","INDUSTRY","100644723","phase-4-real-world-effects-of-mc4r-agonist-therapy-in-bbs-and-severe-genetic-obesity-100644723",false,"NCT07674290","Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity","Real-World Effectiveness, Safety and Patient-reported Outcomes of Setmelanotide in Patients With Bardet-Biedl Syndrome: A Prospective Mono Centric Observational Interventional Study","REAL-MC4","Inclusion Criteria:\n\n* clinical phenotype corresponding to Bardet-Biedl Syndrome\n* genetic testing with notable finding\n\nExclusion Criteria:\n\n* patients younger than the age approved for treatment with setmelanotide","ALL",{"count":71,"type":72},200,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","Bardet-Biedl syndrome (BBS) and other rare disorders associated with impairment of the melanocortin-4 receptor (MC4R) pathway are characterized by severe early-onset obesity, hyperphagia, and substantial morbidity. Setmelanotide, an MC4R agonist, is approved in Europe for selected genetic obesity disorders and reimbursed in Germany for eligible patients. This study aims to evaluate the effectiveness, safety, treatment persistence, metabolic outcomes, and patient-reported outcomes of Setmelanotide under real-world conditions. The registry is designed to allow future inclusion of additional MC4R agonists as they become approved and clinically available. The study will primarily be conducted at University Hospital Essen and will collect longitudinal routine clinical data from pediatric and adult patients receiving MC4R agonist therapy according to approved indications.",[78,79,80,81],"Bardet Biedl Syndrome (BBS)","Bardet Biedl Syndrome","Bardet-Biedl Syndrome (BBS)","Alstrom Syndrome",[17,83,84,85,86,87,88],"Melanocortin-4-receptor","Melanocortin pathway","Bardet-Biedl Syndrome","Hyperphagia","Neurocognitive development","Genetic Obesity","2026-06-23",{"date":91,"type":92},"2026-06-29","ACTUAL",{"date":94,"type":92},"2023-01-01",{"date":96,"type":72},"2030-12-31",{"name":55,"class":6},1]